Takeda buys US biotech PvP Biologics for $330 million

Takeda has bought US biotech PvP Biologics for $330 million, adding a potential new form of therapy for coeliac disease to its pipeline.

The Japanese pharma decided to buy San Diego-based PvP following encouraging results from a phase 1 trial of its TAK-062, also known as Kuma062) for uncontrolled coeliac disease.

Takeda exercised an option to acquire PvP for the upfront $330 million payment, plus development and regulatory milestone payment.

Takeda and PvP Biologics had already struck a development and option agreement, under which PvP Biologics was responsible for conducting research and development through the phase 1 proof-of-mechanism study of TAK-062 in exchange for funding by Takeda according to a pre-defined development plan.

PvP is a tiny biotech that spun out from the University of Washington's Institute for Protein Design in late 2016.

Expertise comes from a team that formerly worked together at Meritage Pharma, which Shire acquired in 2015 prior to its merger with Takeda last year.

TAK-062 is a highly potent super glutenase – a protein that degrades ingested gluten – which has been computationally engineered to treat coeliac disease.

A serious genetically driven autoimmune disease, coeliac disease occurs when abnormal immune responses to gluten peptides lead to small intestinal mucosal damage.

Currently the only available treatment for patients with celiac disease is maintaining a gluten-free diet, which involves strict, lifelong avoidance of exposure to gluten proteins from wheat, barley, and rye, which is not always effective.

The phase 1 study tested TAK-062’s safety and tolerability in healthy volunteers and people with coeliac disease.

The ability of TAK-062 to degrade ingested gluten was studied in healthy volunteers. Takeda plans to submit data from the Phase 1 study for presentation at an upcoming medical congress.

Takeda is planning a Phase 2b efficacy and dose-ranging study of TAK-062 in patients with uncontrolled disease who maintain a gluten-free diet.

Recent population-based studies in the US indicate that the prevalence of celiac disease is around 1% and approximately 0.5% globally.

The threshold of daily gluten that will cause mucosal injury in both adults and children is 10 to 50mg per day – or about 1/100th of a slice of bread.

Gastroenterology is one of Takeda’s strategic focus areas, and the company already markets Entyvio (vedolizumab), a blockbuster approved for treatment of Crohn’s disease.

Other companies developing coeliac disease drugs include GSK, which in September agreed to buy Sitari Pharmaceuticals for its preclinical coeliac drug.

Provention Bio is developing a potential treatment, which it licensed in from Amgen in late 2018.

Takeda has another coeliac drug in its pipeline too - it acquired TAK-101 from COUR Pharmaceuticals in October.